(95 days)
The Disposable Nitrile Examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Disposable Nitrile Examination gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
The provided document describes the acceptance criteria and performance data for Disposable Nitrile Examination Gloves. The study primarily focuses on non-clinical tests to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Reference Standard) | Purpose | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Watertight (ASTM D5151) | To detect holes that leak water and thereby compromise the usefulness of the glove. | Immediately inspect the glove visually for water leakage. Let the glove hang for 2 min and again inspect for water leakage. Batch size: 35000, Sample size: 125 pcs, Inspection level: I, AQL: 2.5, Ac=7, Re=8 | During the test, 0 piece was found with leaks. Hence it falls within the acceptance criteria. | Pass |
| Physical Properties (ASTM D412) | To evaluate the tensile (tension) properties of the glove. | Batch size: 35000, Inspection level: S-2, Sample size: 8 pcs, AQL: 4.0, Ac=1, Re=2.Before Aging: Tensile Strength ≥ 14MPa, Ultimate Elongation ≥ 500%After Accelerated Aging: Tensile Strength ≥ 14MPa, Ultimate Elongation ≥ 400% | Before Aging (Average): Tensile Strength = 16.41MPa, Ultimate Elongation = 540.56%After Accelerated Aging (Average): Tensile Strength = 16.41MPa, Ultimate Elongation = 532.98% (Note: Appears to be a typo/repetition in the document, as "After Accelerated Aging" results are identical to "Before Aging" average for Tensile Strength and very similar for Elongation, usually there's some degradation.) | Pass |
| Physical Dimensions (ASTM D3767-03(2014)) | To measure the length, width, and thickness of the glove. | Length: S: Min. 220 mm, M: Min. 230 mm, L: Min. 230 mm, XL: Min. 230 mmWidth: S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mmThickness: Finger: Min. 0.05 mm, Palm: Min. 0.05 mm | Length: S: Min. 243 mm, M: Min. 249 mm, L: Min. 251 mm, XL: Min. 271 mm (All exceed minimum)Width: S: 86-89mm, M: 97-99mm, L: 106-109mm, XL: 110-120mm (All within tolerance)Thickness: Finger: Min. 0.08 mm, Palm: Min. 0.08 mm (All exceed minimum) | Pass |
| Residual Powder (ASTM D6124) | To determine the amount of residual powder and non-powder solids found on gloves. | Less than 2 mg per glove. | Result: 0.04 (mg/glove) | Pass |
| Biocompatibility (ISO 10993-10, ISO 10993-5) | To assess irritation, sensitization, and cytotoxicity. | Irritation: Not an irritantSensitization: Not a sensitizerCytotoxicity: Did not show potential toxicity to L-929 cells | Under the conditions of the study, not an irritant and not a sensitizer. Did not show potential toxicity to L-929 cells. | Pass |
2. Sample size used for the test set and the data provenance
- Watertight (ASTM D5151): Sample size = 125 pcs (from a batch size of 35000)
- Physical Properties (ASTM D412): Sample size = 8 pcs (from a batch size of 35000)
- Residual Powder (ASTM D6124): Sample size = 5 pcs
- Biocompatibility: Specific sample sizes are not explicitly stated for individual tests but imply testing performed on the device material.
- Data Provenance: The document (K211264) is a 510(k) submission from Shenzhen Shiqiao Science and Technology Co. LTD, China. The testing was conducted as part of this premarket notification. The data is prospective for this submission, meaning it was gathered specifically to support this application.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the tests performed are objective, laboratory-based physical and chemical tests (e.g., measuring dimensions, tensile strength, presence of holes, powder content, biological reactions). They do not involve human interpretation of complex data like medical images or clinical outcomes that would require expert consensus for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the type of objective tests performed on the gloves. Adjudication methods are typically used in studies involving subjective assessments or disagreements among multiple human readers.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or CAD (Computer-Aided Detection) devices, which involve human interaction and diagnostic tasks. The device in question is a disposable medical glove, and its performance is evaluated through physical and chemical properties.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical product (nitrile examination gloves), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed on the gloves is based on:
- Objective measurements and standardized test procedures: For physical properties (tensile strength, elongation, dimensions), watertight integrity, and residual powder content, the ground truth is the direct measurement against the specified acceptance criteria of the ASTM standards.
- Biological assay results: For biocompatibility (irritation, sensitization, cytotoxicity), the ground truth is derived from the results of standardized biological assays (ISO 10993 series) interpreted against established biological safety criteria.
8. The sample size for the training set
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The gloves are manufactured and tested against predefined specifications.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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July 30, 2021
Shenzhen Shiqiao Science and Technology Co. LTD Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K211264
Trade/Device Name: Disposable Nitrile Examination Gloves Regulatory Class: 21 CFR 880.6250 Product Code: LZA Dated: July 8, 2021 Received: July 14, 2021
Dear Boyle Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211264
Device Name Disposable Nitrile Examination gloves
Indications for Use (Describe)
The Disposable Nitrile Examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary-K211264
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.
1.0 submitter's information
Name: Shenzhen Shigiao Science and Technology Co.LTD Address: Unit 2105 ,Tower D. Galaxy World phase II, Minle community ,Minzhi street , Longhua District ,Shenzhen, Guangdong Province, 518000, China Phone Number: +86-18922802487 Contact: MIKKI WAN Date of Preparation: 2021.04.21
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Disposable Nitrile Examination gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
| Manufacturer: | Ever Global (Vietnam) Enterprise Corp |
|---|---|
| Device: | Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color |
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510(k) number: K171422
5.0 Intended use
The Disposable Nitrile Examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device description
The proposed device is Powder Free Disposable Nitrile Examination gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
7.0 Summary comparing technological characteristics with predicate device
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| 510(k) number | K211264 | K171422 | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable NitrileExamination gloves is adisposable device intendedfor medical purposes thatis worn on the examiner'shands to preventcontamination betweenpatient and examiner. | The Disposable PowderFree Nitrile ExaminationGlove, White/Blue/Black/Pink Color is a disposabledevice intended formedical purposes that isworn on the examiner'shands to preventcontamination betweenpatient and examiner. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication,powder free, device color,device name, glove sizeand quantity, DisposableNitrile Examination gloves,Non-Sterile | Single-use indication,powder free, device color,device name, glove sizeand quantity, DisposablePowder Free NitrileExamination Glove,Non-Sterile | Same |
Table1-General Comparison
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| Predicate | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Device(K171422) | XS | S | M | L | XL | ||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Proposed Device | Designation | Size | Tolerance | ||||
| S | M | L | XL | ||||
| Length, mm | 220 | 230 | 230 | 230 | min | ||
| Width, mm | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | SAME |
Table2 Device Dimensions Comparison
Table3 Performance Comparison
| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Colorant | blue | White/Blue/Black/Pink | Analysis1 | |
| PhysicalProperties | BeforeAgingTensileStrength | 14MPa, min | 14MPa, min | SAME |
| UltimateElongation | 500%min | 500%min | SAME | |
| AfterAgingTensileStrength | 14MPa, min | 14MPa, min | SAME | |
| UltimateElongation | 400%min | 400%min | SAME | |
| Comply with ASTM D6319 | Comply with ASTM D6319 | SAME | ||
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | SAME | |
| Powder Content | 0.04 mg/glove | Meet the requirements of ASTM D6124 | SIMILAR |
Analysis1: The proposed device has different colorto the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not effect the safety of proposed device
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| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| Material | Nitrile | Nitrile | SAME |
| Biocompatibility | IrritationUnder the conditions of the study,not an irritant | Comply withISO10993-10 | SAME |
| SensitizationUnder conditions of the study, nota sensitizer. | |||
| CytotoxicityUnder conditions of the study, didnot show potential toxicity to L-929cells. | Comply withISO10993-5 | SIMILAR | |
| Label and Labeling | Meet FDA's Requirement | Meet FDA'sRequirement | SAME |
Table4 Safety Comparison
8.0 Discussion of non-clinical and clinical test performed
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19,Standard Specification For Disposable Nitrile Examination gloves For Medical Application.
Clinical testing is not needed for this device.
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Table 5 Performance Data
| Test Method | Purpose | Acceptance Criteria | Results | Status | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watertight:ASTM D5151(Standard TestMethod for Detectionof Holes in MedicalGloves) | To detectholes thatleak waterand therebycompromisetheusefulness ofthe glove. | Immediately inspected the glove visually forwater leakage. Let the glove hang for 2 min andagain inspect for water leakage.Batch size: 35000, Sample size: 125 pcs,Inspection level: I, AQL: 2.5, Ac=7, Re=8 | During the test, 0 piece was found with leaks.Hence it falls within the acceptance criteria. | Pass | |||||||||||||||||
| Physical Properties:ASTM D412(Standard TestMethods forVulcanized Rubberand ThermoplasticElastomers—Tension) | To evaluatethe tensile(tension)properties ofglove. | Batch size: 35000, Inspection level: S-2,Sample size: 8 pcs,, AQL: 4.0, Ac=1, Re=2 | Pass | ||||||||||||||||||
| Before Aging | After AcceleratedAging | ||||||||||||||||||||
| TensileStrength UltimateElongation ≥14MPa ≥500% | TensileStrength UltimateElongation ≥14MPa ≥400% | TensileStrength(Average) UltimateElongation(Average) 16.41MPa 540.56% | TensileStrength(Average) UltimateElongation(Average) 16.41MPa 532.98% |
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| PhysicalDimensions:(ASTM D3767-03(2014)).Standard Practice forRubber—Measurement of Dimensions | To measurethe length,width andthickness ofglove | Length | S | Min. 220 mm | Length | S | Min. 243 mm | Pass |
|---|---|---|---|---|---|---|---|---|
| M | Min. 230 mm | M | Min. 249 mm | |||||
| L | Min. 230 mm | L | Min. 251 mm | |||||
| XL | Min. 230 mm | XL | Min. 271 mm | |||||
| Width | S | 80±10mm | Width | S | 86-89mm | |||
| M | 95±10mm | M | 97-99mm | |||||
| L | 110±10mm | L | 106-109mm | |||||
| XL | 120±10mm | XL | 110-120mm | |||||
| Thickness | Finger | Min.0.05 mm | Thickness | Finger | Min.0.08 mm | |||
| Palm | Min.0.05 mm | Palm | Min.0.08 mm | |||||
| Residual Powder:ASTM D6124(Standard TestMethod for ResidualPowder on MedicalGloves) | To determinethe amount ofresidual powder andnon-powdersolids foundon gloves. | Less than 2 mg per glove | Sample size : 5 pcsResult: 0.04 (mg/glove) | Pass |
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9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.